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Completed

NCT Number: NCT05037344

iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 6 to 18 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data. The investigators have already successfully performed a feasibility study.The goal of the current proposal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of the feasibility study. Internal testing on iCBT therapy package and developmental workchanges has been done. The investigators are now evaluating effectiveness in an RCT.

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Key information

Conditions

Psychotherapy Intervention Evaluation Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tuebingen

Tübingen, Germany

About this study

In this study the investigators test effectiveness of an internet-based therapy approach for children with obsessive-compulsive disorders in an RCT design with a waiting control group. The investigators are planninng the investigation of 20 patients in each group.Therapy is verified by experts via teleconferences and a therapy app. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list-group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I) and 64 weeks after the first randomization (follow-up II).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescents (ages 6-18) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker
  • German-speaking (child & caretakers)
  • Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone
  • written informed content of the child and his caretaker
  • OCD as highest treatment priority

Exclusion criteria

  • IQ below 70
  • not speaking and understanding German
  • A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment

Treatment and study plan

Cognitive-behavioral psychotherapy

Behavioral

The goal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of our feasibility study. This group will start directly with therapy of 16 weeks. The waiting group gets the same intervention after 16 weeks of waiting.

Primary outcomes

  1. Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    Clinical interview for psychiatric disorders for children and parents.

  2. Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    Interview/questionnaire for obsessive-compusive disorders.

  3. Change in Children's Global Assessment Scale (CGAS)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    The CGAS is a measure of level of functioning in children and adolescents.

  4. Change in Child Behavior Checklist (CBCL/6-18R)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    A 113-item 3-point questionnaire for parents that assesses a wide range of child behavioral and emotional problems.

  5. Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    A 24 item 5 point scale self-report questionnaire for children and parents to quality of life.

  6. Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    A 33-item self-report questionnaire to the impact of OCD symptoms on the psychosocial functioning of the children.

  7. Change in Youth Self-Report (YSR/11-18R)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    A 112 item 3-point scale completed by the children themselves and addresses a variety of behavioral and emotional problems.

  8. Change in Depression Inventory for Children and Adolescents (DIKJ)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    The questionnaire measures depressive symptoms in the children. It has 26 items and a 4 point scale.

  9. Change in Junior temperament and character inventory (JTCI)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale.

  10. Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    The SCARED assesses DSM-IV anxiety symptoms.

  11. Change in Clinical Global Impressions-Severity (CGI-S)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    A clinical 7-point rating scale of symptom severity.

  12. Change in Clinical Global Impressions-Improvement (CGI-I)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    A clinical 7-point rating scale of symptom severity.

  13. Change in Impairment by OCD symptoms

    Time frame: Every day throughout the therapy process

    Children and parents indicate impairment by OCD via app.

  14. Change in Extend of avoidance behavior

    Time frame: Every day throughout the therapy process

    Children and parents indicate extend of avoidance behavior via app.

  15. Change in Daily mood

    Time frame: Every day throughout the therapy process

    Children indicate their mood via app.

  16. Change in How the day has been

    Time frame: Every day throughout the therapy process

    Children indicate how good the day has been via app.

  17. Change in How strong OCD is

    Time frame: Every day throughout the therapy process

    Children and parants indicate how strong OCD is via app.

  18. Change in How the week has been

    Time frame: weekly throughout the therapy process

    Children and parants indicate how the week has been via app.

  19. Change in Anxiety ratings during exposures

    Time frame: Every exposure throughout the therapy process

    Children indicate how high anxiety was during exposures via app.

  20. Change in Heart rate variability

    Time frame: Every day throughout the therapy process

    Heart rate variability as an indicator of stress levels is assessed with wristbands.

  21. Change in time the OCD takes

    Time frame: Every day throughout the therapy process

    Children and parants indicate how much time OCD takes via app.

  22. Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    This questionnaire assesses the core personality traits of children.

  23. Change in Engagement- Fragebogen

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each.

  24. Change in How convinced the patient of his/her OCD thoughts is

    Time frame: every exposure

    assessed by App

  25. Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE)

    Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

    Questionnaire to life quality of parents related to the impairment through the illness of the child.

Other outcomes

  1. Trauma History Questionaire (THQ)

    Time frame: baseline

    This is a 5-point scale and 28 items that measures trauma experience such as sexual abuse or emotional neglect.

  2. Essener Trauma Inventory for Children and Adolescents (ETI-KJ)

    Time frame: baseline

    This questionnaire measures posttraumatic symptoms.

  3. Childhood trauma questionaire (CTQ)

    Time frame: baseline

    This is a 24-item measure to traumatic events.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder II

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 8, 2021
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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